1. Field of the Invention
This invention relates generally to the treatment and prevention of wounds, and more particularly to a device for alleviating or diminishing pressure on a wound, blemish, decubitus ulcer (also known as pressure ulcer or pressure sore) or surgical site.
2. Discussion of Related Art
Pressure sores are a localized area of damaged tissue. Pressure sores occur when soft tissue between a bony prominence and an external surface is compressed for an extended amount of time. Pressure sores, also known as bed sores or decubitus ulcers is usually occur from confinement to a bed, chair or wheelchair. In many instances, pressure sores are a secondary result of another illness or condition that leaves a person immobile.
Patients who are immobile tend to lie in one position for hours on end. This causes a decrease in blood circulation to certain pressure points on the body known as “bony prominences”, such as, for example, ears, shoulders, hips, coccyx (tail bone), buttocks, elbows, ankles and heels, to name a few. These areas are typically the first to break down. The tissue closest to the bone is the most susceptible to pressure sores so a visible skin discoloration may indicate the beginning stages of a pressure sore. The tissue begins to decay from lack of blood circulation. This is the basic formation of decubitus ulcer development.
The prevalence of pressure sores in the United States alone is estimated to be between 1.5 to 3.0 million people. Every year an estimated 60,000 people die from a bedsore complication.
Pressure sores will appear as a red area that can develop into an open wound if left without medical treatment. If pressure sores are left untreated, they can lead to severe health complications and even death.
A decubitus ulcer or pressure sore can range from a very mild pink coloration of the skin, which disappears in a few hours after pressure is relieved on the area, to a very deep wound extending to and sometimes through a bone into an internal organ. These ulcers, as well as other wound types, are classified in stages according to the severity of the wound.
The usual mechanism of forming a decubitus ulcer is from pressure. However, it can also occur from friction, such as by rubbing against a bed sheet, cast, brace, or the like.
The pressure sore and the affected area must be kept clean and clear of any dead tissue. Because pressure sores can expose a patient to infection entering the blood stream, a potentially deadly condition called sepsis, medical care is a very necessary and worthwhile precaution. It has been reported in fact, that sepsis is the 11th leading cause of death, overall. Wound care is a tremendous drain on the national health care system.
The goal in the treatment of pressure sores is to relieve the pressure on and around bony prominences. This can be accomplished by increasing air flow and blood flow to the affected area so that pressure sores do not continue to worsen. Frequent turning is mandatory to alleviate pressure on the wound and to promote healing. Support devices can help relieve some of the pressure on the pressure sores. Wound care products comprise devices for open wound support, such as medicated dressings, wraps, protectors, mattress pads and cushions.
Although these devices and treatments are helpful, they remain ineffective in many respects. Dressings and wraps, for example, are in direct physical contact with the wound surface. Consequently, these devices apply pressure on the wound area. This pressure results in a longer healing time and the affected areas are therefore more prone to the formation of decubitus ulcers.
Mattress pads and cushions also have considerable drawbacks. The mattress pads and cushions available today have a definite geometrical shape and size which cannot be easily altered to adapt to individual needs.
Wound protectors are typically used during the transportation of accident victims. These protectors often cannot be applied to bed sores or some surgical sites because of their limited design.
Thus, there is clear and distinct need for a device which will effectively alleviate or diminish pressure on a wound by elevating the affected area, 0.25 inches to 3.0 inches above a surface while also avoiding direct physical contact with the wound, blemish, pressure ulcer or surgical site.
It is known in the art to use a cushioning means for the purpose of elevating the body and increasing air flow to pressure points, thereby reducing the incidence of pressure or decubitus ulcers.
For example, U.S. Pat. No. 5,511,260 naming as inventor, Dinsmoor III et al. and U.S. Pat. No. 4,614,000 naming as inventor Mayer, U.S. Pat. No. 4,959,059 naming as inventor Eilender, U.S. Pat. No. 4,962,769 naming as inventor Garcia, U.S. Pat. No. 5,462,519 naming as inventor Carver and U.S. Pat. No. 4,425,676 naming as inventor Crane, teach a mattress replacement or treatment overlay for the purpose of elevating the body and increasing air flow to certain pressure points, thereby reducing the incidence of pressure or decubitus ulcers.
These cushioning means, however, are large and bulky and cannot be easily manipulated to alter their shape or size to accommodate to individual needs.
U.S. Pat. No. 4,779,297 naming as inventor, Sturges, teaches that it is known in the art to have a compact cushion support article for the purpose of elevating the body, increasing air flow to pressure points, and thereby reducing the incidence of pressure or decubitus ulcers.
These devices however, have a definite geometric shape and size, for example a “donut” shape. This shape cannot be altered and hence its usefulness is limited. Similarly, the “Waffle Extended Care Cushion” from EHOB, Inc., although compact, cannot be manipulated with ease to adopt a different shape or size.
U.S. Patent Application No. 20030163072 naming as inventor, Cristian Hueso teaches a conic arch device that provides physical protection to any superficial wound. However, as with the “donut” and “waffle” shaped cushions, the shape of this device is not capable of being easily altered and cannot be adapted to accommodate individualized needs.
U.S. Pat. No. 6,009,577 naming as inventor, Day, U.S. Pat. No. 5,638,564, naming as inventor Greenwalt, U.S. Pat. No. 5,615,432 naming as inventor Van Ohlen III and U.S. Pat. No. 6,595,935 naming as inventor Gerstmar teach that it is known in the art to have a crescent or U-shaped type pillow as a cushioning means for the head and neck. These devices, however, have not been adapted for the treatment or prevention of pressure sores, decubitus ulcers, etc. and their usefulness in that respect is limited.
Thus, there is a definite, distinct, and even urgent need for a device in the treatment of decubitus ulcers, wounds, blemishes, etc. which will alleviate pressure by elevating the body 0.25 to 3.0 inches above a surface, without covering the wound, blemish, pressure ulcer or surgical site and which is capable of easily being manipulated to conform to individualized needs.
The present invention accomplishes these objectives and substantially departs from the conventional concepts and designs of the prior art.